The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Sinuscope.
| Device ID | K944186 |
| 510k Number | K944186 |
| Device Name: | SINUSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Mark Ziegler |
| Correspondent | Mark Ziegler Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-11-07 |